NZ621752B2 - Systems and methods to increase rigidity and snag-resistance of catheter tip - Google Patents
Systems and methods to increase rigidity and snag-resistance of catheter tip Download PDFInfo
- Publication number
- NZ621752B2 NZ621752B2 NZ621752A NZ62175212A NZ621752B2 NZ 621752 B2 NZ621752 B2 NZ 621752B2 NZ 621752 A NZ621752 A NZ 621752A NZ 62175212 A NZ62175212 A NZ 62175212A NZ 621752 B2 NZ621752 B2 NZ 621752B2
- Authority
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- New Zealand
- Prior art keywords
- catheter
- body member
- infusion system
- tubular body
- hole
- Prior art date
Links
- 238000001802 infusion Methods 0.000 claims description 50
- 230000002792 vascular Effects 0.000 claims description 46
- 239000012530 fluid Substances 0.000 claims description 27
- 239000000463 material Substances 0.000 claims description 18
- 238000004891 communication Methods 0.000 claims description 4
- 238000009792 diffusion process Methods 0.000 abstract description 57
- 210000003462 Veins Anatomy 0.000 description 27
- 238000001990 intravenous administration Methods 0.000 description 23
- 238000000034 method Methods 0.000 description 20
- 210000003491 Skin Anatomy 0.000 description 11
- 238000003780 insertion Methods 0.000 description 11
- 150000002500 ions Chemical class 0.000 description 10
- 230000002093 peripheral Effects 0.000 description 10
- 210000001519 tissues Anatomy 0.000 description 9
- 239000002872 contrast media Substances 0.000 description 8
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- 238000001125 extrusion Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000002560 therapeutic procedure Methods 0.000 description 4
- 210000004369 Blood Anatomy 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 238000002591 computed tomography Methods 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000002861 polymer material Substances 0.000 description 3
- TZCXTZWJZNENPQ-UHFFFAOYSA-L Barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 2
- 238000002405 diagnostic procedure Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 230000037227 Blood Loss Effects 0.000 description 1
- 208000001380 Diabetic Ketoacidosis Diseases 0.000 description 1
- 206010015866 Extravasation Diseases 0.000 description 1
- 206010051283 Fluid imbalance Diseases 0.000 description 1
- 206010022114 Injury Diseases 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 229940035295 Ting Drugs 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium(0) Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- JCXGWMGPZLAOME-UHFFFAOYSA-N bismuth Chemical compound [Bi] JCXGWMGPZLAOME-UHFFFAOYSA-N 0.000 description 1
- 229910052797 bismuth Inorganic materials 0.000 description 1
- GUTLYIVDDKVIGB-UHFFFAOYSA-N cobalt Chemical compound [Co] GUTLYIVDDKVIGB-UHFFFAOYSA-N 0.000 description 1
- 229910052803 cobalt Inorganic materials 0.000 description 1
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- 239000000945 filler Substances 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 238000010329 laser etching Methods 0.000 description 1
- 230000003902 lesions Effects 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 230000002572 peristaltic Effects 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000036633 rest Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000001340 slower Effects 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- KISFEBPWFCGRGN-UHFFFAOYSA-M sodium;2-(2,4-dichlorophenoxy)ethyl sulfate Chemical compound [Na+].[O-]S(=O)(=O)OCCOC1=CC=C(Cl)C=C1Cl KISFEBPWFCGRGN-UHFFFAOYSA-M 0.000 description 1
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- 229910052719 titanium Inorganic materials 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 229910052721 tungsten Inorganic materials 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M2025/0073—Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0015—Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Abstract
venous catheter having a catheter tip comprising recessed (248) diffusion holes (250,251) for increasing the snag-resistance of the venous catheter. Also disclosed are systems and methods for providing axial ridges (266) interposed between diffusion holes for increasing the rigidity of the vented catheter tip. By having the apertures within such portions recessed from the outer surface of the catheter tip snag-resistance is enhanced. catheter tip. By having the apertures within such portions recessed from the outer surface of the catheter tip snag-resistance is enhanced.
Description
SYSTEMS AND METHODS TO INCREASE RIGIDITY AND
SNAG—RESISTANCE OF CATHETER TIP
BACKGROUND OF THE INVENTION
The present invention relates generally to vascular infusion s and components,
including catheter lies and devices used with catheter assemblies. In particular,
the present invention relates to systems and methods for increasing the rigidity and snag-
resistance of a catheter tip of a vascular infusion system having catheter hole arrays to
provide enhanced infusion flow rates, lower system pressures, and reduced catheter exit jet
velocities. Additionally, the present invention relates to ing the overall rigidity of a
thin-walled structure.
Vascular access devices are used for communicating fluid with the anatomy of a patient. For
e, vascular access devices, such as catheters, are ly used for infusing fluid,
such as saline on, various medicaments, and/or total parenteral nutrition, into a patient,
withdrawing blood from a patient, and/or monitoring various parameters of the patient’s
vascular system.
A variety of clinical circumstances, including massive trauma, major surgical procedures,
massive burns, and certain e states, such as pancreatitis and diabetic ketoacidosis,
can produce nd circulatory volume ion. This depletion can be caused either
from actual blood loss or from internal fluid imbalance. In these clinical settings, it is
frequently necessary to infuse blood and/or other fluid rapidly into a patient to avert serious
COHSCqUCIlCOS.
Additionally, the y to inject large quantities of fluid in a rapid manner may be desirable
for certain other medical and diagnostic procedures. For example, some diagnostic imaging
procedures utilize contrast media enhancement to improve lesion conspicuity in an effort
to increase early stic yield. These procedures necessitate Viscous contrast media be
injected by a specialized “power injector” pump intravenously at very high flow rates, which
establishes a contrast bolus or small plug of contrast media in the bloodstream of the patient
which results in enhanced image quality.
Power ion procedures generate high pressures within the infusion system, thereby
requiring specialized vascular access devices, extension sets, media transfer sets, pump
syringes, and bulk or led st media syringes. As the concentration (and thereby
ity) and infusion rate of the contrast media are sed, bolus density also increases
resulting in better image quality Via computed tomography (CT) attenuation. Therefore, a
—Page 1-
current trend in healthcare is to increase the bolus density of the contrast media by increasing
both the concentration of the st media and the rate at which the media is infused into
the patient, all ofwhich ultimately drives system pressure ements higher.
Intravenous infusion rates may be defined as either routine, generally up to 999 cubic
centimeters per hour (cc/hr), or rapid, generally between about 999 cc/hr and 90,000 cc/hr
(1.5 liters per minute) or higher. For some stic procedures utilizing viscous contrast
media, an injection rate of about 1 to 10 ml/second is needed to ensure sufficient bolus
concentration. Power ions of viscous media at this injection rate produce significant
back pressure within the infusion system that commonly s in a failure of the infusion
system components.
Traditionally, rapid infusion therapy entails the use of an intravenous catheter attached to
a peristaltic pump and a fluid source. A patient is infused as a tip portion of the catheter is
inserted into the vasculature of a patient and the pump forces a fluid through the catheter and
into the patient’s vein. Current rapid infusion therapies e a catheter and catheter tip with
geometries cal to those used with traditional, routine infusion rates. These ries
include a tapering catheter tip such that the fluid is accelerated as the fluid moves through
the catheter tip and exits into a patient’s ature. This acceleration of the infused fluid is
undesirable for several reasons.
For example, the tapered catheter results in a greater backpressure for the remainder of the
catheter assembly. This effect is undesirable due to the limitations of the pumping capacity
of the infusion pump as well as the limited structural integrity of the components and
ponents of the infilsion system. For e, if the backpressure becomes too great,
the pump’s efficiency may decrease and n seals or connections within the infusion
system may fail. Additionally, the fluid acceleration in the catheter tip results in a recoil
force that may cause the catheter tip to shift within the patient’s vein thereby displacing the
er and/or damaging the patient’s vein and/or injection site. Fluid acceleration also
increases the jet velocity of the infusant at the tip of the catheter. In some procedures, the
fluid jet may pierce the patient’s vein wall thereby leading to extravasation or ation.
Not only is this uncomfortable and l to the patient, but infiltration may also prevent the
patient from receiving the needed therapy.
To overcome undesirable backpressures and increased acceleration of d fluids, some
intravascular systems include arrays of diffuser holes provided in and around the tip portion
of the intravenous catheter. Examples of arrays of diffuser holes and diffuser hole geometries
are ed in US. Patent Application Nos. 12/427,633 and 13/022,501, each ofwhich are
-Page 2—
incorporated herein by reference.
In general, diffuser holes increase the surface area of the catheter tip opening thereby
decreasing fluid pressure at the catheter tip opening. However, addition of diffuser holes
at or near the tip of a catheter also reduces the buckling resistance of the catheter thereby
making the er tip more susceptible to crushing during insertion. As a result, the
addition of diffuser holes may result in failed catheterization and physical pain to the t.
r, addition of diffuser holes provides the er with a non-continuous outer surface
that may snag or catch on the opening of the patient’s skin and/or vein through which the
catheter is inserted. This too may result in failed catheterization, physical pain and/or
physical damage to the patient.
Thus, while methods and systems currently exist to reduce exit velocity of an infusant during
rapid infusion procedures, challenges still exist. Accordingly, it would be an improvement in
the art to augment or even replace current techniques with other techniques.
BRIEF SUMMARY OF THE INVENTION
The systems and methods of the present disclosure have been developed in response to
problems and needs in the art that have not yet been fully resolved by currently available
infusion systems and methods. Thus, these systems and methods are developed to provide
for safer and more efficient rapid infiision procedures.
One aspect of the t invention provides an improved vascular access device for use in
combination with a vascular infusion system capable of rapidly delivering an infusant to the
vascular system of a patient. The vascular access device generally es an intravenous
catheter red to access the vascular system of a patient. The enous catheter is
coupled to the ar on system via a section of intravenous g. The material of
the intravenous catheter may include a polymer or metallic maten'al compatible with infusion
procedures.
In some embodiments, a tip n of the intravenous catheter is d to include a
plurality of diffusion holes. The tip portion generally comprises a tapered , wherein
the outer and inner surface of the tip taper towards the distal end of the catheter. The d
outer surface es a smooth transition between the narrow diameter of the catheter tip
opening and the larger diameter of the catheter tubing. Thus, as the tip of the catheter is
introduced into the vein of a patient, the tapered outer surface facilitates easy insertion of the
catheter through the access hole. The tapered inner surface is lly provided to tightly
contact the outer surface of an introduce-r needle housed within the lumen of the catheter.
The introducer needle is provided to create an opening into the vein ofpatient through which
-Page 3-
the catheter tip is inserted. The tapered inner surface ensures a tight seal between the inner
surface of the catheter and the outer e of the needle. Following placement of the
catheter, the introducer needle is removed.
In some implementations, a eral er is provided comprising a catheter body having
an outer surface, a proximal end, a distal end, a lumen extending between the proximal and
distal ends, and a distal lumen opening, the catheter further including a recess formed in
the outer surface of the catheter body. In some implementations, a diffusion hole is further
positioned within the recess through a wall thickness of the catheter body. As such, the
recessed on of the diffusion hole is removed fiom directly contacting the skin or other
tissues of the patient during insertion of the catheter. Accordingly, the diffusion hole is
prevented from snagging the skin or tissues of the t.
In some implementations, a method for manufacturing a snag-resistant, vented er is
provided, wherein the method includes the steps of providing a catheter body having an outer
surface, a proximal end, a distal end, a lumen extending between the proximal and distal
ends, and a lumen opening. The method further includes the steps of providing a recess in
the outer surface of the er body, and further providing a diffusion hole in the recess
through a wall thickness of the catheter body. As such, the recessed location of the diffusion
hole is removed from directly contacting the skin or other s of the patient during
insertion of the catheter. Accordingly, the diffusion hole is prevented from snagging the skin
or tissues of the patient.
Further, in some implementations, a peripheral er is provided comprising a catheter
body having a predetermined wall thickness, the er body member having a proximal
end, a distal end, a lumen extending n the proximal and distal ends, and a distal lumen
opening, the catheter body further having a truncated length to access a peripheral vein
of a patient. In some implementations, the peripheral er further comprises a recess
formed in the outer surface of the catheter body, wherein a hole is provided within the recess
through the predetermined wall thickness and in communication with the lumen. As such,
the ed location of the diffusion hole is removed from ly contacting the skin or
other tissues of the t during insertion of the catheter. Accordingly, the diffusion hole is
prevented from snagging the skin or tissues of the patient.
The present invention fiuther includes methods for manufacturing an intravenous catheter for
diffusing an infusant. Some methods include the steps of providing an intravenous catheter
and g a plurality of red holes through the wall thickness of the intravenous
catheter. Some methods ofthe present invention further include using a laser drill to provide
—Page 4-
the various staggered holes. Still further, some methods of the present invention include
extrusion and co—extrusion processes for providing the catheter body and various other
features discussed in detail below.
BRIEF PTION OF THE SEVERAL VIEWS OF THE DRAWINGS
In order that the manner in which the above-recited and other es and advantages of
the invention are obtained will be readily understood, a more particular description of the
invention briefly described above will be rendered by reference to c embodiments
thereof'which are illustrated in the appended drawings. These gs depict only typical
embodiments of the invention and are not therefore to be considered to limit the scope of the
invention.
Figure 1 is a perspective view of an infusion system in accordance with a representative
ment ofthe present invention.
Figure 2 is a detailed perspective view of a catheter in accordance with a representative
embodiment ofthe present invention.
Figure 3 is a perspective view of a catheter tip in accordance with a representative
embodiment ofthe present invention.
Figure 4 is a section side View ofthe catheter tip in accordance with a representative
embodiment of the t invention.
Figure 5 is a cross-section side View of a catheter tip during catheterization in accordance
with a entative embodiment ofthe present invention.
Figure 6A is a cross-section end View of a catheter tip during catheterization in accordance
with a representative embodiment ofthe present invention.
Figure 6B is a cross-section end view of a catheter tip during eatheten'zation, the catheter tip
incorporating a stiffening material in accordance with a representative embodiment of the
present invention.
Figure 7 is a detailed cross-section end view of a catheter tip having a flow breaking feature
in accordance with a representative ment of the present invention.
Figure 8 is a perspective view of a catheter tip in accordance with a entative
embodiment of the present ion.
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the present invention will be best understood by reference to the drawings,
wherein like reference numbers indicate identical or functionally similar elements. It will be
y understood that the components of the t invention, as generally described and
illustrated in the figures herein, could be arranged and ed in a wide variety of different
-Page 5-
configurations. Thus, the following more detailed description, as represented in the figures,
is not intended to limit the scope of the invention as d, but is merely representative of
presently preferred embodiments ofthe invention.
The systems and methods of the present invention are generally designed for use in
combination with a vascular infusion system capable of y delivering an nt to the
vascular system of a patient. Referring now to Figure l, a vascular on system 100 is
shown, in accordance with a representative embodiment of the present invention. on
systems of this type are ly configured to operate at internal pressures up to 2000
psi. Many systems operate in the range of 75 to 2000 psi, while specific devices of this type
operate at 100, 200, and 300 psi. The vascular infusion system 100 comprises a vascular
access device 112 coupled to an injector pump 120 via a coiled extension set 130. In some
embodiments, the infusion system 100 further comprises a safety device 140 positioned
between the vascular access device 112 and the or pump 120. In some ments, a
safety device 140 is provided to automatically occlude the fluid path of the infusion system
100, thereby preventing excessive pressure buildup in downstream infusion components.
An injector pump 120 generally comprises a fluid pumping apparatus configured to rapidly
r an infusant, such as blood, medicaments, and CT scan contrast agents to a patient’s
vascular system. Desirable nts may also include various fluids often of high viscosity
as required for medical and diagnostic procedures. In some embodiments, the injector
pump 120 comprises a power injector capable of delivering an infusant to a patient at flow
rates from about 10 mL/hour up to about 1200 mL/minute. In some embodiments, a high
on flow rate is desirable for medical procedures which require enhanced bolus density
of an nt in a patient’s vascular system. For example, a trend in stic imaging
procedures is to e contrast media enhancement, which requires more s st
media to be pushed into a patient at a higher flow rate, thereby resulting in increased image
quality. Thus, in some embodiments an injector pump 120 and a vascular access device 112
are selected to compatibly achieve a desired infusion flow rate.
A coiled extension set 130 generally comprises flexible or exible polymer tubing
configured to deliver an infusant from the injector pump 120 to the vascular access device
112. The extension set 130 includes a first coupler 132 for connecting the extension set 130
to a downstream device 112 or 140. The extension set 130 also includes a second coupler
134 for connecting the extension set 130 to the injector pump 120. A coiled configuration
of the extension set 130 generally prevents undesirable kinking or occlusion of the set 130
during infusion procedures. However, one of skill in the art will appreciate that the extension
—Page 6-
set 130 may include any configuration e of efficiently delivering an infusant from an
injector pump 120 to the patient via a vascular access device 112. In some embodiments,
the extension set 130 is coupled between a syringe and a vascular access device whereby
an infusant is manually injected into a patient. In other embodiments, the infusion system
comprises only a syringe and a vascular access device, in accordance with the t
ion.
The vascular access device 1 12 generally comprises a peripheral intravenous catheter I 14.
A peripheral intravenous catheter 114 in accordance with the present invention generally
comprises a short or truncated catheter ly 13mm to 52mm) that is inserted into a small
peripheral vein. Such catheters generally comprise a diameter of approximately a 14 gauge
catheter or smaller. Peripheral intravenous catheters 114 are typically ed for temporary
placement. The short length of the catheter 114 facilitates convenient ent of the
catheter but makes them prone to premature dislodging from the vein due to nt of
the patient and/or recoil forces experienced during infusion procedures. Furthermore, unlike
midlirte or central eral ers, peripheral intravenous ers 114 in accordance
with the present invention comprise a tapered catheter tip 146 to accommodate use with an
introducer needle (not shown) designed to aid in insertion of the catheter 114.
An introducer needle is typically inserted through the catheter 114 such that a tip of the
needle extends beyond the tapered tip 146. The tapered geometry of the tapered tip 146
conforms tightly to the outer surface of the introducer needle. Both the outer surface and
the inner surface of the tip 146 are tapered towards the distal end of the catheter 114. The
outer surface of the tip 146 is tapered to provide a smooth transition from the smaller profile
of the introducer needle to the larger profile of the catheter outer diameter. ion of the
introducer needle into the vein of the patient provides an opening into the vein through which
the tapered tip 146 of the catheter 114 is inserted. The tapered outer surface of the tip 146
enables easy insertion of the catheter 114 into the opening. Once the peripheral intravenous
catheter 114 is inserted into the vein of the patient, the introducer needle (not shown) is
removed from the lumen ofthe catheter 114 to permit infusion via the catheter 114.
A d infusant is typically delivered to the catheter 114 via a section of enous
tubing 1 16 coupled to the catheter 114. In some embodiments, a y-adapter 118 is d to
an end ofthe tubing 116 Opposite the catheter 114, enabling the vascular access device 112 to
be coupled to the remainder of the vascular infusion system 100. One of skill in the art will
appreciate the possible variations and specific features of available vascular access devices
1 12, as are commonly used in the medical and ch professions. For example, in some
-Page 7—
rnents a catheter 114 in accordance with the present invention may include additional
access sites, clamps, parallel intravenous lines, valves, couplers, introducer needles, coatings,
and/or materials as desired to fit a specific application.
Referring now to Figure 2, a catheter 214 is shown in accordance with a representative
embodiment of the present invention. Catheter 214 generally comprises a catheter adapter
218 configured to house a r body member 220. Catheter adapter 218 further includes
an inlet port 230 that is coupled to a section of intravenous tubing 216. The section of
intravenous tubing 216 is fiirther coupled to am infusion components, as shown and
described in tion with Figure 1, above.
The er adapter 218 facilitates delivery of an nt within the intravenous tubing 216
to a patient Via the tubular body member 220. An inner lumen of the catheter adapter 218 is
in fluid communication with both an inner lumen of the intravenous tubing 216 and an inner
lumen of the tubular body member 220. In some ments, catheter adapter 218 further
comprises an access port 222. The access port 222 is generally provided to permit direct
access to the inner lumen of the catheter adapter 218. In some embodiments, the access port
222 is accessed via a needle and a syringe to deliver an infusant to a patient via the tubular
body member 220. In other embodiments, an introducer needle or guide wire is inserted
into the access port 222 and advanced through the inner lumen of the tubular body member
220. In some embodiments, a tip portion of the introducer needle or guide wire (not shown)
extends beyond a tip n 240 of the tubular body member 220. As such, the tip portion
of the introducer needle or guide wire may provide an opening into the vascular system of
a patient into which the tubular body member 220 is inserted. ing placement of the
tubular body member 220 into the vein of the patient, the introducer needle or guide wire
is removed from the access port 222 thereby establishing fluid communication between the
tubular body member 220, the catheter adapter 218 and the enous tubing 216.
In some embodiments, the tubular body member 220 comprises an enous catheter.
The intravenous catheter 220 generally comprises a flexible or semi—flexible biocompatible
material, as ly used in the art. In some embodiments, the intravenous catheter
220 ses a polymer material, such as polypropylene, polystyrene, polyvinylchloride,
polytetrafluoroethylene, and the like. In other ments, the intravenous catheter 220
comprises a ic material, such as surgical steel, titanium, cobalt steel, and the like.
The tubular body member 220 may comprise any length, where the length is selected based
on the intended application of the catheter 214. For some applications, the tubular body
member 220 is inserted into a peripheral vein ofthe patient. In other applications, the tubular
—Page 8-
body member 220 is inserted into a central vein of the patient. In some embodiments, the tip
portion 240 of the tubular body member 220 is modified to include a recess 248 formed in the
wall thickness of the tubular body member 220, as shown in Figures 2 and 3.
With continued reference to Figures 2 and 3, recess 248 generally comprises a small
concavity defined by adjacent lls or chamfered surfaces 249. In some embodiments
recess 248 further comprises a diffusion hole 250 to facilitate rapid infusion applications.
Diffusion hole 250 is generally provided to divert fluid from the main l of flow
through the inner lumen of the tubular body member 220. As such, ion hole 250
effectually slow the jet of infusant which issues from the catheter tip 240 during rapid
infilsion procedures. Additionally, diffusion hole 250 increases the accumulative area of the
catheter tip opening 242 to relieve the overall pressure in the vascular infusion system 100.
In some embodiments, diffiision hole 250 ses one or more side holes which meet the
requirements of International Standard ISO 10555-2, section 4.4.3.
In some ments, tubular body member 220 r comprises a plurality of recesses, as‘
shown in Figure 4. For example, in some embodiments tubular body member 220 comprises
a second recess 258 positioned te recess 248. Second recess 258 further comprises a
second diffusion hole 251 positioned opposite diffusion hole 250. In some embodiments,
a plurality of recesses and diffusion holes are provided in adjacent, annular rings along
the length of tubular body member 220. In other embodiments, the ity of recess and
diffusion holes are provided in a staggered pattern of nt, annular rings along the length
of tubular body member 220. As such, an upstream recess and diffusion hole is ned
with an adjacent, downstream recess and diffusion hole.
es 248 and 258 are generally provided by manufacturing methods known in the art.
For example, in some embodiments recesses 248 and 258 are provided via an extrusion
process. In other embodiments, recesses 248 and 258 are provided via an etching process,
such as laser etching. Further, diffusion holes 250 and 251 are lly provided by
manufacturing methods known in the art. For example, in some embodiments the plurality of
ion holes 250 and 251 are provided with a laser drill.
In some embodiments, recesses 248 and 258 are rically positioned on tubular
body member 220 so as to prevent catheter tip 240 from being displaced due to lateral
forces causes by an infusant exiting diffusion holes 250 and 251. For example, in some
embodiments a tubular body member 220 is provided having three recesses, wherein each
recess comprises a diffusion hole radially spaced approximately 120° from an nt
diffiision hole. In further example, some embodiments comprise a tubular body member 220
-Page 9—
having greater than three recesses and greater than three diffusion holes.
atively, in some embodiments tubular body member 220 is modified to e a
plurality of axial ridges 266 formed on the outer e of tubular body member 220 by
extrusion or another heat forming method. Diffusion holes 250 and 251 may be placed
between axial ridges 266, as shown. During catheterization (i.e.: insertion of tubular body
220 into the vascular system of a patient), axial ridges 266 lift the skin and other tissues of
the patient over diffusion holes 250 and 251 thereby preventing tissue from getting snagged
in the diffusion holes, as discussed below.
In some embodiments, diffusion holes 250 and 251 are formed through the catheter wall 260
such that an inner surface 252 of each hole is ed at an angle 262 that is oblique to an
irmer surface 272 of the catheter lumen 270. In some ments, angle 262 is between
about 15° to about 75°. In other embodiments, angle 262 is approximately 45°. r, in
some embodiments angle 262 is approximately 90° relative to inner surface 252.
In some embodiments, the bore angle 262 further affects the positioning of the catheter
within the vein of t. For example, when inserted into a vein the venous catheter
generally extends through the skin and into the vein at approximately 30°. As such, the tip of
the venous catheter commonly contacts or rests against the inner wall of the vein opposite the
insertion site of the catheter. As fluid flow increases, high jet velocity from the catheter tip is
exerted directly on the inner wall of the vein. However, when the tip of the venous er
is modified to include diffusion holes, the diverted infusant that issues from the diffusion
holes pushes the catheter tip away from the vein wall resulting in a centralized position of the
er tip within the vein. Thus, the jet velocity from the tip is directed into the fluid stream
of the vein rather than into the vein wall. Accordingly, in some embodiments the bore angle
262 of diffusion holes 250 and 251 is selected to achieve optimal centralized positioning of
catheter tip 240 within the vasculature of the t during infusion procedures.
Referring now to Figure 5, a distal end portion 242 of venous catheter 214 is shown, in
accordance with a representative embodiment of the present invention. As previously
sed, in some embodiments an outer e of catheter tip 240 is tapered so as to
provide a gradual transition from catheter opening 242 of tip 240 to the diameter of tubular
body 220. Further, in some ments the outer surface of catheter tip 240 is tapered so
as to provide a gradual transition fiom the outer er of an introducer needle 300 to the
diameter oftubular body 220, as shown.
In some embodiments, venous catheter 214 comprises an over—the—needle catheter. Thus,
in some embodiments an opening 320 is provided within the skin 302 or other tissue of
—Page 10—
the patient by an introducer needle 300 housed within the catheter lumen 270. In some
embodiments, a tip 310 of the introducer needle 300 is positioned external to the catheter
lumen 270 so as to provide an exposed cutting surface by which to e an opening 320
into the ature of the patient. Upon advancing the venous catheter into the patient, the
tapered configuration of tubular body 220 permits easy passage of the catheter’s tip 240 in
opening 320.
As shown, axial ridges 266 lift the skin 302 or other tissues of the patient away from
diffusion holes 250 and 251 during catheterization. Alternatively, recesses 248 and
258 position diffusion holes 250 and 251 away from opening 320 thereby ting
undesirable contact or snagging between the ion holes and opening 320. Thus, in some
embodiments axial ridges 266 and/or recesses 248 and 258 increase the esistance of
catheter tip 240, as shown in Figure 6A.
In some embodiments, the inclusion of diffusion holes at or near the tip of a short catheter
may result in a reduction of buckling ance for the catheter thereby making the catheter
more susceptible to ng during catheterization. Accordingly, in some embodiments
axial ridges 266 further increase the bending and buckling stiffness of catheter tip 240,
thereby minimizing the risks of catheter tip crushing or buckling during insertion. One
having ordinary skill in the art will ore iate and recognize that the stiffening
effect of axial ridges 266 may be accomplished by any number of structural ations
wherein the thickness and/or rigidity of the catheter wall 260 between diffusion holes 250 and
251 is increased to withstand compression and/or sheer forces during insertion.
For example, in some embodiments the rigidity of the catheter wall 260 oned
n diffusion holes 250 and 251 is sed by the addition of a stiffening material
290, as shown in Figure 6B. In some embodiments, ning material comprises a rigid
or semi-rigid radiopaque material, such as a wire or an extruded filler material which
may include a chemical salt of bismuth or barium, or an element such as platinum or
tungsten. In some embodiments stiffening material 290 comprises barium sulfate. In other
embodiments, stiffening material 290 comprises a polymer material having an increased
density as compared to the remaining polymer material of the venous catheter 214. In some
embodiments, venous catheter 214 and stiffening material 290 are coextruded, wherein
stiffening material 290 is embedded within the wall thickness of the tubular body member
220. In other embodiments, stiffening material 290 is applied directly to the external surface
oftubular body member 220, thereby forming axial ridges 266.
—Page 11—
Referring now to Figure 7, in some embodiments sidewalls 249 further comprise a flow
breaking feature 280. A “flow breaking feature” refers to a e of the diffusion hole 250
and/or a physical feature adjacent to the ion hole 250 that substantially breaks up, thins,
or slows a jet of infusant exiting the diffusion hole 250 so that the jet will lose speed more
quickly Within the vein.
Figures 2-7 generally depict circular diffusion holes. However, in some embodiments one
or more diffusion holes may be non—circular. For example, in some embodiments flow
breaking feature 280 may include a flow disrupter, elongated diffusion hole geometries, and
diffusion hole orientations such that the axis of flow of two or more diffusion holes collide.
In some embodiments, flow ng feature 280 is a flow ter comprising an inward
projection that contacts the jet of infusant exiting diffusion hole 250. In other embodiments,
flow breaking feature 280 is a flow disrupter including a pointed extension. r, in
some embodiments feature 280 comprises a ity of inward projections. An “inward
projection” refers to a n of a diffusion hole’s periphery which projects toward the inner
n ofthe diffiision hole.
In some embodiments, a single diffusion hole includes more than one flow breaking
features. Examples of flow breaking es are described herein, including at least inward
projections, wedged extensions, an elongated diffusion hole ry, and diffiision hole axis
orientations that result in collisions with other fluid jets. For example, in some embodiments,
a diffusion hole includes an inward projection and has an axis orientation that collides with
that of another hole. In addition, in some ments the diffusion hole further includes a
wedged extension. In other embodiments, other combinations of flow breaking features are
combined to provide a less harmful, more effective catheter diffusion hole and diffusion hole
array configuration.
From the ing, it will be seen that one or more flow breaking features can be included
on one or more catheter diffusion holes on a catheter tip. The flow breaking features can
substantially break up, thin, or slow a jet of fluid exiting a diffusion hole so that the jet will
lose speed more quickly within the vein and cause less damage to vessel walls. In particular,
flow breaking features are particularly advantageous when used in rapid infusion therapy
that uses highly nt velocities to rapidly introduce a bolus of fluid into a patient through
the catheter tip. During these procedures, one or more flow breaking features of a diffusion
hole can increase on patient comfort, decrease patient pain, allow for greater on
velocities, and prevent vessel damage.
—Page 12-
Referring now to Figure 8, in some ments recess 288 and axial ridges 296 are
extended along the length of tubular body 220, thereby odating a plurality of
recessed diffusion holes 298. Accordingly, the sum of the exiting infnsant jets from recessed
diffusion holes 298 will produce a fluid infusion with less impact energy and which poses
a lesser risk to the patient’s vessel walls. In some embodiments, recess 288 comprises a
near recess thereby providing a non-linear alignment of recessed diffusion holes 298.
For example, in some embodiments recess 288 comprises a helical recess, wherein recess
288 circumscribes the outer surface of tubular member 220 in a helical fashion. In other
embodiments, recess 288 comprises a plurality of longitudinal recesses, wherein a portion of
each longitudinal recess is interested with a ridge thereby dividing each longitudinal recess
into two or more ns.
The present invention may be embodied in other specific forms without departing from
its structures, methods, or other essential teristics as broadly described herein and
claimed hereinafter. The described embodiments are to be considered in all respects only
as illustrative, and not. restrictive. The scope of the invention is, therefore, ted by the
appended claims, rather than by the ing description- All changes that come within the
meaning and range of equivalency ofthe claims are to be embraced within their scope.
-Page 13—
Claims (14)
- l. A vascular infusion system, comprising: a vascular access device red to be coupled to an injector pump for injecting an infusant into the vasculature of a patient, the vascular access device sing a er through which the infusant is injected, the catheter comprising a catheter adapter that couples to the injector pump and a r body member that s from the catheter adapter, the tubular body member having an outer surface, a proximal end, a distal end, a lumen extending between the al and distal ends, a tapered tip at the distal end, and a distal lumen opening, the catheter adapter further including an introducer needle that is contained within the lumen and extends distally from the distal lumen opening of the tubular body member; characterized in that the tubular body member comprises: a recess formed in the outer surface, the recess sing ng sidewalls and a surface, the recess extending along the tapered tip of the tubular body member in a direction parallel to the length of the tubular body member; and at least one hole positioned in the recess, the hole being formed in the surface through a wall thickness of the r body member and in fluid communication with the lumen.
- 2. The vascular infusion system of claim 1, wherein the at least one hole comprises a ity of holes.
- 3. The vascular infusion system of claim 1, further comprising a plurality of recesses, wherein each of the recesses comprises at least one hole.
- 4. The vascular infusion system of claim 1, wherein the tapered tip is tapered from an outer diameter of the introducer needle to an outer diameter of the tubular body member.
- 5. The vascular infusion system of claim 4, further comprising a flow breaking feature positioned on one or both of the lls.
- 6. The vascular infusion system of claim 5, wherein the flow breaking feature includes a flow disrupter.
- 7. The vascular infusion system of claim 6, wherein the flow disrupter is an inward projection.
- 8. The vascular infusion system of claim 1, wherein a bore angle of the hole is oblique to an inner wall surface of the lumen.
- 9. The ar infusion system of claim I, wherein the tubular body member further comprises a stiffening material embedded within the wall thickness of the tubular body member.
- 10. The vascular infusion system of claim 9, wherein the stiffening material comprises a plurality of strips of the stiffening material that are spaced within and extend along the length of the tapered tip.
- 1 1. The vascular infusion system of claim 10, wherein the stiffening material ses a radiopaque material.
- 12. The ar infusion system of claim I, further comprising a flow breaking e that is positioned nt to the hole.
- 13. The vascular infusion system of claim 12, wherein the flow breaking feature comprises a ar protrusion that extends around the hole.
- 14. The vascular infusion system of claim 3, wherein the plurality of recesses comprise two recesses positioned on opposite sides of the tubular body member, and the at least one hole in one recess and the at least one hole in the other recess are symmetrically positioned such that when the infiisant is injected through the holes, the forces generated by the infusant leaving each hole are balanced. IS. The vascular infusion system of claim 1, wherein the catheter r includes an access port through which the lumen of the tubular body member is accessible.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/223,178 US9402975B2 (en) | 2011-08-31 | 2011-08-31 | Systems and methods to increase rigidity and snag-resistance of catheter tip |
US13/223,178 | 2011-08-31 | ||
PCT/US2012/049859 WO2013032647A1 (en) | 2011-08-31 | 2012-08-07 | Systems and methods to increase rigidity and snag-resistance of catheter tip |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ621752A NZ621752A (en) | 2016-07-29 |
NZ621752B2 true NZ621752B2 (en) | 2016-11-01 |
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